Medications & Supplements/Prescription Drugs

EYLEA (aflibercept) Injection Recalled for Syringe Breakage and Sterility Risk

Agency Publication Date: May 2, 2024

Summary

Regeneron Pharmaceuticals Inc. is recalling 251,504 syringes of EYLEA (aflibercept) Injection (2 mg) because the pre-filled syringes may break. Because of these breakage reports, the company cannot guarantee that the medication inside remains sterile. This prescription medication is a single-dose injection used for certain eye conditions and was distributed to healthcare providers nationwide.

Risk

A broken syringe can compromise the sterile barrier, potentially introducing bacteria or other contaminants into the medication. This poses a risk of serious eye infections or other complications for patients receiving the injection.

What You Should Do

This recall involves EYLEA (aflibercept) Injection, 2 mg (0.05mL) single-dose pre-filled syringes sold under NDC 61755-005-01.
Identify affected products by checking for lot number 8231500321 (Expiration 10/31/24) or lot numbers 8231500335, 8231500333, 8231500334, 8231500339, and 8231500347 (all with Expiration 1/30/25).
Stop using the recalled product immediately and quarantine any remaining stock from these specific lots.
Contact Regeneron Pharmaceuticals Inc. or your medical distributor directly to arrange for the return of the affected syringes.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report a problem.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: EYLEA (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution)

Variants: 2 mg, Single-dose Pre-filled Syringe

Lot Numbers:

8231500321 (Exp 10/31 24)

8231500335 (Exp 1/30/25)

8231500333 (Exp 1/30/25)

8231500334 (Exp 1/30/25)

8231500339 (Exp 1/30/25)

8231500347 (Exp 1/30/25)

NDC:

61755-005-01

Rx only; Manufactured by Regeneron Pharmaceuticals, Inc. at 777 Old Saw Mill River Road, Tarrytown, NY 10591.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94481

Status: Resolved

Manufacturer: Regeneron Pharmaceuticals Inc

Sold By: Wholesalers; Hospitals; Clinics; Medical Distributors

Manufactured In: United States

Units Affected: 251,504 syringes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves EYLEA (aflibercept) Injection, 2 mg (0.05mL) single-dose pre-filled syringes sold under NDC 61755-005-01.

Identify affected products by checking for lot number 8231500321 (Expiration 10/31/24) or lot numbers 8231500335, 8231500333, 8231500334, 8231500339, and 8231500347 (all with Expiration 1/30/25).

Stop using the recalled product immediately and quarantine any remaining stock from these specific lots.

Contact Regeneron Pharmaceuticals Inc. or your medical distributor directly to arrange for the return of the affected syringes.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report a problem.

Affected Products

Product: EYLEA (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution)

Variants: 2 mg, Single-dose Pre-filled Syringe

Lot Numbers:

8231500321 (Exp 10/31 24)

8231500335 (Exp 1/30/25)

8231500333 (Exp 1/30/25)

8231500334 (Exp 1/30/25)

8231500339 (Exp 1/30/25)

8231500347 (Exp 1/30/25)

NDC:

61755-005-01

Rx only; Manufactured by Regeneron Pharmaceuticals, Inc. at 777 Old Saw Mill River Road, Tarrytown, NY 10591.